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ACGT leverages both extensive practical experience and reliable, current regulatory knowledge of cell and gene therapies. ACGT principal Scott R. Burger, MD, has directed process development, validation and GMP manufacturing in support of over 75 cell or gene therapy clinical trials. Karen Edward has broad experience in all aspects of cell therapy operations including directing manufacturing operations, design, implementation and management of quality systems and regulatory compliance.

  • Scott R. Burger, MD
    Principal
    CVBio
  • Karen Edward, BS, MT (ASCP)
    Affiliate
    CVBio